SEATTLE, July 9, 2018
/PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) and Servier today
announced that the pivotal Phase III trial (PIX306) evaluating
PIXUVRI® (pixantrone) combined with rituximab in
comparison to gemcitabine combined with rituximab in patients with
aggressive B-cell non-Hodgkin lymphoma (NHL) did not meet its
primary endpoint of an improvement in progression-free survival
(PFS).
"We are disappointed with the outcome of the PIX306 trial and
will proceed to conduct a thorough review of clinical data to
assess the next steps for the PIXUVRI program," commented
Adam Craig, MD, PhD, CEO of CTI
BioPharma. "We would like to express our appreciation to the
patients, families and investigators who participated in the
study."
Results from the study will be submitted to a peer-reviewed
journal for publication.
About PIX306
The PIX306 trial is a randomized,
multicenter trial comparing pixantrone combined with rituximab
versus gemcitabine combined with rituximab in patients with
aggressive B-cell non-Hodgkin lymphoma (NHL).
The PIX306 trial enrolled 312 patients who had relapsed after
therapy with CHOP-R or an equivalent regimen and were ineligible
for stem cell transplant. The primary endpoint was progression-free
survival (PFS) while overall survival (OS), complete response rate
(CR), overall response rate (ORR) and safety were secondary
endpoints.
For more information about the PIX306 trial, please
visit
https://www.clinicaltrials.gov/ct2/show/NCT01321541.
The ClinicalTrials.gov identifier is NCT01321541.
About Non-Hodgkin Lymphoma (NHL)
NHL is a blood
cancer that affects the lymphatic system, which is defined as a
network of vessels and glands that run throughout the
body.1 The lymphatic system is a key component of the
immune system, as it plays a role in destroying old or abnormal
cells and fighting bacteria and other infections.2
NHL can occur in different parts of the body from the lymph
nodes in the neck to the liver or spleen, but also in other organs
such as the stomach, small bowel, bones, brain, testicles or
skin.3 Around 168,000 new cases of NHL are
diagnosed in the United States and
Europe every year.
About PIXUVRI® (pixantrone)
PIXUVRI® is the first treatment in the European Union
indicated as monotherapy for the treatment of adult patients with
multiply relapsed or refractory aggressive non-Hodgkin B-cell
lymphoma (NHL).4 PIXUVRI® is a cytotoxic
medicine that works by interfering with the DNA within cells and
preventing them from making more copies of DNA. This means that the
cancer cells cannot divide and eventually die.5
PIXUVRI® has not been approved by the U.S. Food
and Drug Administration in the United
States (US).
PIXUVRI® has conditional marketing authorization
from the European Commission for prescription in the European Union
(EU) as a monotherapy for the treatment of adult patients with
multiply relapsed or refractory aggressive NHL.6
Conditional marketing authorizations are granted in the EU if all
the following requirements are met: the benefit-risk balance of the
product is positive, it is likely that the applicant will be able
to provide comprehensive data, unmet medical needs will be
fulfilled, the benefit to public health of the medicinal
product's immediate availability on the market outweighs the risks
due to need for further data.7 The PIX306 report will be
submitted to the EMA for evaluation by the end of December 2018.
PIXUVRI® is mentioned in the ESMO guidelines as
an anthracycline-like drug with reduced cardiotoxicity, which
demonstrated some efficacy in heavily treated
patients.8
The Summary of Product Characteristics (SmPC) has the full
prescribing information, including the safety and efficacy profile
of PIXUVRI® in the approved indication. The SmPC is
available at www.ema.europa.eu
CTI granted Servier rights to commercialize the drug globally in
all markets except the US. The two companies continue to work
closely to build the efficacy and safety evidence for
PIXUVRI® and to ensure that as many eligible
patients as possible are benefitting from it.
About Servier
Servier is an international
pharmaceutical company governed by a non-profit foundation, with
its headquarters in France
(Suresnes). With a strong international presence in 148 countries
and a turnover of 4.152 billion euros
in 2017, Servier employs 21,600 people worldwide. Entirely
independent, the Group reinvests 25% of its turnover (excluding
generic drugs) in research and development and uses all its profits
for development. Corporate growth is driven by Servier's constant
search for innovation in five areas of excellence: cardiovascular,
immune-inflammatory and neuropsychiatric diseases, cancer and
diabetes, as well as by its activities in high-quality generic
drugs. Servier also offers eHealth solutions beyond drug
development.
Becoming a key player in oncology is part of Servier's long-term
strategy. Currently, there are nine molecular entities in clinical
development in this area, targeting gastric and lung cancers and
other solid tumors, as well as different types of leukemia and
lymphomas. This portfolio of innovative cancer treatments is being
developed with partners worldwide, and covers different cancer
hallmarks and modalities, including cytotoxics, proapoptotics,
immune, cellular and targeted therapies, to deliver life-changing
medicines to patients.
More information: www.servier.com
Find us on Social Media: LinkedIn, Facebook, and Twitter
About CTI BioPharma
CTI BioPharma Corp. is a
biopharmaceutical company focused on the acquisition, development
and commercialization of novel targeted therapies covering a
spectrum of blood-related cancers that offer a unique benefit to
patients and healthcare providers. CTI BioPharma has a late-stage
development pipeline, including pacritinib for the treatment of
patients with myelofibrosis. CTI BioPharma is headquartered in
Seattle, Washington. For
additional information and to sign up for email alerts and get RSS
feeds, please visit www.ctibiopharma.com.
Servier Media Relations
Sonia MARQUES:
media@servier.com – Tel.: +33 (0)1 55 72 40 21 / + 33 (0)7 84 28 76
13
Karine BOUSSEAU: media@servier.com – Tel.: +33 (0)1 55 72 60 37
CTI BioPharma Contacts
Julia Balanova (investors):
jbalanova@troutgroup.com – Tel.: +1 646 378 2936
Rich Allan (media):
rallan@troutgroup.com – Tel.: +1 646 378 2958
Forward-Looking Statements
This press release contains
forward-looking statements, which are generally statements that are
not historical facts. Forward-looking statements can be identified
by the words "expects," "anticipates," "believes," "intends,"
"estimates," "plans," "will," "outlook" and similar expressions,
including those related to the potential therapeutic potential of
PIXUVRI®, the submission of the study to a peer-reviewed
journal, and the timing, scope and outcome of interactions with and
submissions to regulators. Forward-looking statements are based on
management's current plans, estimates, assumptions and projections,
and speak only as of the date they are made. Servier and
CTI BioPharma undertake no obligation to update any forward-looking
statement in light of new information or future events, except as
otherwise required by law. Forward-looking statements involve
inherent risks and uncertainties, most of which are difficult to
predict and are generally beyond the control of either company.
Actual results or outcomes may differ materially from those implied
by the forward-looking statements as a result of the impact of a
number of factors, many of which are discussed in more detail in
the public reports of CTI BioPharma filed with the Securities
and Exchange Commission.
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1 NHS
Conditions webpage. NHL Cancer. Available at
http://www.nhs.uk/Conditions/non-hodgkins-lymphoma/Pages/Definition.aspx
[last accessed July 2018].
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2 Cancer
Research UK. Lymphatic System. Available at
http://www.cancerresearchuk.org/about-cancer/what-is-cancer/body-systems-and-cancer/the-lymphatic-system-and-cancer
[last accessed July 2018].
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3 Cancer
Research UK. What is NHL cancer. Available at
http://www.cancerresearchuk.org/about-cancer/type/non-hodgkins-lymphoma/about/what-is-lymphoma
[last accessed July 2018]
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4 Pixuvri
Summary of Product Characteristics, Available at:
https://www.medicines.org.uk/emc/medicine/29829 [last accessed July
2018]
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5 European
Medicines Agency. About Pixuvri. Available at:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002055/human_med_001549.jsp&mid=WC0b01ac058001d124
[last accessed July 2018].
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6 Evaluate
Group. NICE Publishes Final Guidance on PIXUVRI® (pixantrone).
Available at
http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=490415
[last accessed July 2018].
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7 European
Medicines Agency. Authorisation details. Available at
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002055/human_med_001549.jsp&mid=WC0b01ac058001d124
[last accessed July 2018]
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8 Tilly H
et al. Diffuse large B-cell lymphoma (DLBCL): ESMO Clinical
Practice Guidelines for diagnosis, treatment and follow-up. Annals
of Oncology (2015). Volume 26 (suppl 5); v116-v125. Available at
http://www.esmo.org/Guidelines/Haematological-Malignancies/Diffuse-Large-B-Cell-Lymphoma
[last accessed July 2018]
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